Modules
Quality Management
Deviation tracking, CAPAs, and quality system oversight
Quality Management
Manage deviations, corrective and preventive actions (CAPAs), and quality events with full traceability.
Deviations
Track any departure from approved procedures — from minor documentation errors to critical process failures.
Severity Levels
- Critical — Patient safety impact, requires CAPA within 24 hours
- Major — Significant process deviation, investigation required
- Minor — Documentation or administrative deviation
CAPAs
Corrective and Preventive Actions linked to deviations, EM excursions, or audit findings.
CAPA Lifecycle
Initiated <Icon name="ArrowRight" size={12} /> Investigation <Icon name="ArrowRight" size={12} /> Root Cause <Icon name="ArrowRight" size={12} /> Action Plan <Icon name="ArrowRight" size={12} /> Implementation <Icon name="ArrowRight" size={12} /> Effectiveness Verification <Icon name="ArrowRight" size={12} /> ClosedBusiness Rules
| Rule | Description |
|---|---|
| Q1 | Critical deviations must have CAPA within 24 hours |
| Q2 | Patient impact deviations require PIC sign-off |
| Q3 | CAPAs cannot close until effectiveness verified by different user |
| Q4 | Deviations open > 30 days escalate to VP |